Clinical Research Nurse
2 weeks ago
Job Description
The Clinical Research Nurse is responsible for coordinating and overseeing clinical operations of clinical trials. The role involves assessing, planning, implementing, and evaluating patient care in clinical research studies. The Clinical Research Nurse works under the supervision of the principal investigator responsible for the clinical trials.
Responsibilities
- Assist the principal investigator in the preparation of proposed clinical trials by reviewing trial protocol and ensuring appropriate departments are notified.
- Ensure all protocol revisions, informed consents, continuing reviews, and serious adverse events are submitted to the appropriate IRB in a timely manner.
- Act as liaison between principal investigators and sub-investigators on all regulatory issues and changes within the protocol.
- In collaboration with the principal investigator, review studies for feasibility and evaluate potential competition with other protocols before submission.
- Review study with principal investigator to outline a budget and finalize it with the budget coordinator.
- Recruit and evaluate study patients, schedule appointments, and conduct interviews.
- Identify the needs of the patient population served and modify care delivery to meet those needs.
- Review medical records for potential study patients and ensure all laboratory test results and procedures are documented.
- Instruct potential study patients, designated caregivers, physicians, and other staff members on aspects of patient care, available trials, treatments, and side effects.
- Assist investigator with consent process, ensuring study patients understand clinical trials and obtain written informed consent.
- Educate study patients about informed consent procedures and HIPAA authorization.
- Document study patients' medical histories, perform nursing assessments, and monitor their progress during clinical trials.
- Evaluate and develop study patient education materials and provide instructions on drug administration and other medical information.
- Plan for study patients' appropriate care under the direction of a physician or advanced practice nurse.
- Notify the principal investigator of any adverse events or serious adverse events, including drug toxicity or unexpected side effects.
- Report all serious adverse events to the sponsor and IRB according to established timelines.
- Coordinate research activities, including scheduling laboratory tests, radiology testing, and other medical exams.
- Perform and/or oversee clinical duties such as EKGs, processing/shipping of blood serum, urine, and communicating results to the PI or APN.
- Act as the principal investigator's representative when appropriate, including communicating with sponsors and their representatives, the IRB, and other medical personnel.
- Maintain accurate, complete, up-to-date records on each patient participating in a clinical trial protocol.
- Ensure study patients' clinical trial-related activities are billed appropriately and reconcile drug study account records with research finance personnel.
- Prepare and assist with sponsor monitor site visits, ensuring all supporting documentation records are adequate and available.
- Develop case report forms and/or databases for physician-initiated studies as needed.
- Assist the principal investigator in preparing for publication and work with analysts on data queries.
- Provide education to all departments and clinical areas where the study is performed.
- Attend research meetings and conferences as required.
- Participate in staff meetings and in-service education of nursing and medical staff.
- Adhere to the standards identified in the Medical Center's Organizational Competencies.
- Clinical Research Experience (minimum of 2 years)
- New York Registered Nurse License
- Oncology Certified Nurse (OCN) certification is a plus
- Experience in a high-volume and high-pressure environment
- Ability to work effectively in a diverse team
- Strong communication and organizational skills
The work environment is fast-paced and requires the ability to handle high volumes and pressure effectively. The team is diverse and supportive, and the role offers flexible work hours, typically consisting of four 10-hour days from 8 AM to 6 PM or 9 AM to 7 PM. The job involves standing for a minimum of 6 hours a day and occasionally lifting, pushing, and pulling a minimum of 5 lbs.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, Diversity And Inclusion Are a Bridge Towards The Equity And Success Of Our People. DE&I Are Embedded Into Our Culture Through
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
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